01
Scientific rigor
We staff and advise with people who have done the work in pharma, biologics, and medical devices - not generalists learning your regulations on the job.
About Viltis
Built for the complexity of regulated science.
Consulting and expert resourcing for pharmaceutical, biologics, life science, and medical device organizations.
Company
Expert solutions. Ethical delivery. Headquarters in San Diego.
Viltis is a consulting firm working with pharmaceutical, biologics, life science, and medical device companies. We are headquartered in San Diego and support clients across the US on regulatory compliance, mainly FDA standards for pharmaceutical and medical device quality.
We take on work we can stand behind. That means clear scope, honest timelines, and specialists who understand the constraints a regulated organization is already under.
What defines Viltis
Principles that guide every engagement
02
Operational integrity
We track the work against its schedule and its budget, and we raise a risk to either one while there is still time to act on it.
03
Client accountability
We say what we will deliver, own misses when they happen, and stay reachable when priorities shift mid-engagement.
How we support clients
Depth across the product lifecycle
Quality Assurance
Experienced quality leads run work from kickoff through closeout. They hold the schedule and the budget, and they raise slippage early rather than at handover.
Remediation Services
When findings or overdue CAPAs pile up, we help find the real cause and put a fix in place that holds - without theater that looks good in a slide and fails on the floor.
Clinical Operations
Clinical operators who have run studies before - building or augmenting teams so startup, monitoring, and closeout stay on a realistic clock.
Scientific
Scientific and CMC specialists who sit with your team long enough to understand the actual problem, then deliver work that matches that problem - not a generic package.
Engineering
Process, facilities, and validation engineers who close staffing gaps without a long ramp - people who already know GxP manufacturing floors and change control.
Areas of work
Six practice areas
Browse the services that support regulated product development and quality oversight.
Quality
GMP, GCP, and ISO 13485 quality experts - audit-ready, experienced, and regulatory-aligned.
Clinical
Clinical consulting across pharmaceuticals, medical devices, and biologics - from trial operations to real-world evidence.
Regulatory
Expert regulatory consulting for pharmaceuticals, medical devices, and biologics across FDA and EU pathways.
Engineering
Process engineering, validation, facilities qualification, and manufacturing readiness for regulated environments.
Scientific
Scientific and technical consulting across nonclinical development, CMC, bioanalytics, and due diligence.
Pharmacovigilance
Drug safety, ICSR management, signal detection, and global pharmacovigilance compliance across development and post-market.
Location
Headquartered in San Diego, CA.
We support clients across the United States with consulting and expert resourcing for FDA-aligned quality and regulated operations.
Have a similar challenge?
Speak with a Viltis consultant about regulatory, quality, clinical, or technical priorities.